360° view on regulations for medical devices in EU - US

Julie Carty

At HealthXL we empower innovators to solve healthcare problems through collaboration. On Wednesday, we hosted a webinar featuring one of our HealthXL Members - ICON plc. ICON plc is a clinical research organization (CRO) to the pharmaceutical, biotechnology & medical device industries. At the webinar, Dr. Dairine Dempsey, Vice President of Strategic Regulatory Affairs at ICON, a Ph.D. pharmacist, with over 15 years' experience as a pharmaceutical regulator, provided us with anoverview of the regulatory landscape for medical devices in digital health.We were also hosting Prof. Brendan Buckley, Chief Medical Officer of ICON, who gave us an overview of ICON and Dr. Anand Iyer, Chief Strategy Officer of WellDoc, who are commercializing BlueStar, the first FDA-cleared mobile prescription therapy for Type 2 diabetes.

Five insights from the webinar:

Classification of your product is based on the level of risk associated with your product.

EU: The Medical device directive in Europe is undergoing significant reform currently. There are no binding rules on the difference between healthcare apps/software & medical devices.

FDA: There is a guidance released in 2013 for mobile medical apps which introduced the concept of enforcement discretion for devices that may meet the definition of a device but for which FDA will not enforce medical device requirements, however, all medical devices must comply US FDA Quality System Regulation.

Common ground for US & EU: you must have a locally designated person in respective region where you are not based in that region.